New Delhi: Two different types of antibiotic injections manufactured by India's Emcure Pharmaceuticals sold in the US by Heritage Pharmaceuticals Inc are being recalled following concerns over quality control processes.
According to information available on the USFDA site, 24,344 vials of Rifampin injection (600 mg per vial) manufactured by Emcure Pharmaceuticals have been recalled by Heritage Pharmaceuticals Inc.
Rifampin is an antibiotic used to treat tuberculosis along with other medications.
The other recall is for an unspecified number of colistimethate injection (150 mg per vial), used for treating bacterial infections.
The USFDA said the reason for the two recalls was lack of assurance of sterility and "the firm is recalling two injectable products due to concerns with quality control processes".
Both the recalls come under Class II, a situation in which "use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote", as per the USFDA.
In a similar development, Mylan Institutional LLC is recalling 936 vials of cancer treatment drug DOXOrubicin Hydrochloride Injection, 200 mg/100 mL (2 mg/mL), manufactured by Bengaluru-based Onco Therapies.
According to the USFDA, the recall is on account of mix up in packaging stating "Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL".
Mylan Institutional LLC is also recalling 78,090 vials of nicardipine hydrochloride injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial manufactured in India.
The medicine is used for treatment of hypertension.
The USFDA said the reason for the recall was "subpotent drug and failed impurities/degradation specifications".